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PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100114-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100443-PIP01-22-M02 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100064-PIP01-21-M01 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 03/11/2021
MHRA-100067-PIP01-21-M01 (update)
  • nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100160-PIP01-21-M01 (update)
  • TOCILIZUMAB
  • Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy
  • RoActemra
  • RoActemra
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100046-PIP01-21-M01 (update)
  • cenobamate
  • Treatment of epilepsy
  • ONTORZY
  • Xcopri
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 03/11/2021
MHRA-100046-PIP01-21-M02 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Xcopri
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100046-PIP01-21-M04 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Xcopri
  • Ontozry
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100083-PIP01-21-M01 (update)
  • Human Fibrinogen (INN) / Human Thrombin (INN)
  • HUMAN THROMBIN
  • HUMAN FIBRINOGEN
  • Treatment of: haemorrhage from a surgical procedure
  • CSF leakage from a neurosurgical procedure
  • EVICEL, Solution for sealant
  • EVARREST, Sealant matrix (withdrawn EU MAA)
  • EVICEL
  • EVICEL
  • EVICEL
  • Other: blood-derived topical haemostats
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/11/2021
MHRA-100174-PIP01-21
  • Encequidar
  • Treatment of breast cancer
  • Treatment of soft tissue sarcoma
  • Paxorlea
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/11/2021
MHRA-100049-PIP01-21-M01 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/11/2021
MHRA-100049-PIP01-21-M02 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100059-PIP01-21-M01 (update)
  • roxadustat
  • Treatment of anaemia due to chronic disorders
  • EVRENZO
  • EVRENZO
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100802-PIP01-22-M01 (update)
  • roxadustat
  • Treatment of anaemia due to chronic disorders
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100092-PIP01-21-M01 (update)
  • VENETOCLAX
  • Haematopoietic and lymphoid malignant neoplasms
  • Treatment of solid tumour malignant neoplasms
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100092-PIP01-21-M02 (update)
  • VENETOCLAX
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
  • Venclyxto
  • Vencylxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/11/2022
MHRA-100152-PIP01-21
  • cosibelimab
  • Treatment of cutaneous squamous cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/12/2021
MHRA-100235-PIP01-21-M01 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100235-PIP01-21-M02 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100102-PIP01-21-M01 (update)
  • MOMETASONE FUROATE
  • INDACATEROL ACETATE
  • Treatment of asthma
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021